Indirect comparison and cost-utility of dabigatran etexilate and rivaroxaban in the treatment and extended anticoagulation of venous thromboembolism in a UK setting

Abstract

Background:

Acute venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is traditionally managed with a short course of parenteral anticoagulation followed by 3–6 months of a vitamin-K antagonist. Non-vitamin K oral anticoagulants (NOACs) do not require routine monitoring and dose adjustment, thus potentially provide an alternative treatment option.

Methods and results:

Because of the lack of head-to-head clinical studies, an indirect comparison was conducted of dabigatran etexilate and rivaroxaban based on the respective phase III clinical trial. The derived relative safety and efficacy estimates were used to evaluate the cost-utility of dabigatran compared with rivaroxaban in the treatment and secondary prevention of VTE. The results of the indirect comparison showed no significant difference between dabigatran and rivaroxaban in avoiding recurrent VTE following index PE, index DVT, or DVT/PE combined, in treatment and extended anticoagulation. Dabigatran has significantly less major or clinically relevant bleeds (MCRBE) compared to rivaroxaban in treatment after index DVT and treatment after DVT or PE combined, but was not significantly different from rivaroxaban after index PE or in extended anticoagulation. In cost-utility deterministic analyses, dabigatran was projected dominant in all analyzed settings, given its marginally lower total cost and marginally higher QALYs gained compared to rivaroxaban. Probabilistic analyses results showed a high likelihood of dabigatran being considered good value for money in the UK, in treatment and in secondary prevention of VTE.

Conclusion:

The cost-effectiveness evaluations showed that dabigatran can be considered the dominant treatment strategy compared to rivaroxaban in the patients’ sub-groups considered, given the projected marginally higher clinical benefits and lower treatment costs.

Keywords::

• Venous thrombosis
• Dabigatran
• Rivaroxaban
• Indirect comparison
• Cost-effectiveness

Transparency

Declaration of funding

This study was funded by Boehringer Ingelheim International GmbH.

Declaration of financial/other relationships

Boehringer Ingelheim International GmbH employed IMS Health Consulting to conduct the present study and write the manuscript, of which MDF and ML are employees. TS and AU are employees of and VH is a consultant for Boehringer Ingelheim. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors of this paper acknowledge the work of Sorrel E Wolowacz (RTI) and James Brockbank (RTI) who supported the development of the cost-effectiveness model.